Thrombocytopenia is frequently chronic, severe, and occasionally refractory to platelet transfusions in patients with marrow failure syndromes and hematological malignancies. Despite prophylactic allogeneic platelet transfusions, maintaining platelet counts in a safe range is often difficult in this patient population. Bleeding complications occur in approximately 20% of patients with acute myeloid leukemia and in up to 58% of hematopoietic stem cell transplants recipients. Thus, there is a need to identify improved therapeutic methods to control thrombocytopenia.
AMICAR® is an FDA approved product containing epsilon aminocaproic acid (EACA) (6-aminohexanoic acid) reported to enhance hemostasis when fibrinolysis contributes to bleeding. For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, the label of AMICAR® indicates using 5 AMICAR® 1000 mg tablets or 10 AMICAR® 500 mg tablets (5 g) or 20 milliliter of AMICAR® oral solution (5 g) that is to be administered during the first hour of treatment.
Kalmadi et al. report that EACA reduces transfusion requirements in patients with thrombocytopenic hemorrhage. Cancer, 2006, 107, 136-140. Schwartz et al., report EACA in the treatment of patients with acute promyelocytic leukemia and acquired alpha-2-plasmin inhibitor deficiency. Ann Intern Med, 1986, 105(6):873-7. See also Wassenaar et al., Hematol Oncol, 2008, 26(4):241-6; Garewal and Durie, Scand J Haematol, 1985, 35, 497-500; Deysine and Cliffton, Annals of the New York Academy of Sciences, 1964, 115, 291-297; Mannucci, New England Journal of Medicine, 1998, 339, 245-253; and U.S. Pat. No. 5,415,863.
Antun et al. report epsilon aminocaproic acid prevents bleeding in severely thrombocytopenic patients with hematological malignancies. Cancer. 2013, 1;119(21):3784-7.
References cited herein are not an admission of prior art.